CLC1600 Chemistry Analyzer with ISE Module

Basic Information

• Brand Name: CLC1600 Chemistry Analyzer with ISE Module
• Primary DI: 00817302023114
• Version / Model: CLC-ISE
• Catalog Number: CLC-ISE
• Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION
• Labeler DUNS: 962385787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-05
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8bfb22a4-8825-443d-b077-87d85f465cb3

Device Description

CLC1600 Clinical Chemistry Anallyzer with ISE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52866	Multiple electrolyte IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.	No	Active
61927	Multi-modality clinical specimen analysis system IVD	An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817302023114	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Depth	35	Inch
Height	44	Inch
Width	50	Inch
Device Size Text, specify			CLC1600 Clinical Chemistry Anallyzer with ISE

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 8 – 30 Degrees Celsius